Mari A. Griffioen, PhD, RN, is Assistant Professor, University of Delaware School of Nursing, Newark. Joseph Glutting, PhD, is Professor, University of Delaware School of Education, Newark. Robert V. O'Toole, MD, is Professor, University of Maryland School of Medicine, Baltimore. Angela R. Starkweather, PhD, RN, ANCP-BC, CNRN, FAAN, is Professor, University of Connecticut School of Nursing, Storrs, CT. Debra Lyon, PhD, RN, FAAN, is Professor, University of Florida Gainesville College of Nursing. Susan G. Dorsey, PhD, RN, FAAN, is Professor, University of Maryland School of Nursing, Baltimore. Cynthia L. Renn, PhD, RN, FAAN, is Associate Professor, University of Maryland School of Nursing, Baltimore.
Nurs Res. 2020 Mar/Apr;69(2):149-156. doi: 10.1097/NNR.0000000000000407.
BACKGROUND: Traumatic injury is a major source of chronic pain, particularly for individuals with traumatic fracture of the fibula and/or tibia (lower extremity fracture [LEFx]). Although several factors (e.g., older age, being female, high pain intensity at time of initial injury) have been identified as risk factors for chronic pain associated with LEFx. Comprehensive biopsychosical models to predict the odds of transitioning from acute to chronic pain after LEFx are needed to better understand the underlying processes, predict risk for chronic pain, and develop personalized therapies for individuals at higher risk for developing chronic pain. OBJECTIVE: The aim of the study was to outline the study design that will be used to examine the physiological, psychological, and genetic/genomic variables-models that predict the transition from acute to chronic pain after LEFx. METHOD: This prospective descriptive cohort study will enroll 240 participants with a fibula and/or tibia fracture and 40 controls with no LEFx. Data will be collected during an in-hospital baseline visit, five in-person clinic visits (6 weeks, 12 weeks, 24 weeks, 52 weeks, and 24 months), and seven online between-visit surveys (2 weeks, 4 weeks, 8 weeks, 10 weeks, 16 weeks, 20 weeks, and 18 months) from participants with LEFx and at concordant intervals from controls. Measures will consist of 19 questionnaires characterizing pain and psychological status, neurophysiological testing for peripheral sensory nerve function, and peripheral blood samples collections for RNA sequencing. Illumina standard protocols will be used to sequence RNA, and read counts will be used to measure gene expression. ANALYSIS: Direct-entry, multiple logistic regression will be used to produce odds ratios expressing the relative risk on each explanatory variable when controlling for other predictors/covariates in the model. CONCLUSION: This study is one of the first to longitudinally characterize the biopsychosocial variables associated with a clinically relevant problem of the transition from acute to chronic posttraumatic fracture pain in individuals with LEFx. Results from this study will be used to construct predictive risk models of physiological, psychological, and genetic/genomic variables associated with increased risk for transitioning from acute to chronic pain status after LEFx. This work will lead to a better understanding of the trajectory of pain and relevant variables over time; initiate a better understanding of variables associated with risk for transitioning from acute to chronic pain; and, in the future, could provide a foundation for the identification of novel therapeutic targets to improve the outcomes of individuals with LEFx.
背景：创伤是慢性疼痛的主要来源，尤其是对于腓骨和/或胫骨（下肢骨折[LEFx]）创伤性骨折的个体。尽管已经确定了一些因素（例如，年龄较大、女性、初始损伤时的疼痛强度较高）是与 LEFx 相关的慢性疼痛的危险因素。需要综合的生物心理模型来预测 LEFx 后从急性疼痛转为慢性疼痛的几率，以便更好地了解潜在过程，预测慢性疼痛风险，并为处于更高慢性疼痛风险的个体制定个性化治疗方法。
目的：本研究旨在概述将用于检查生理、心理和遗传/基因组变量模型的研究设计，这些模型可预测 LEFx 后从急性疼痛转为慢性疼痛的几率。
方法：这是一项前瞻性描述性队列研究，将纳入 240 名腓骨和/或胫骨骨折患者和 40 名无 LEFx 的对照组。数据将在住院基线访视期间、5 次门诊访视（6 周、12 周、24 周、52 周和 24 个月）以及 LEFx 患者的 7 次在线访视之间的调查（2 周、4 周、8 周、10 周、16 周、20 周和 18 个月）和对照组的相应时间间隔内收集。测量将包括 19 个问卷，用于描述疼痛和心理状况，外周感觉神经功能的神经生理测试，以及外周血样收集进行 RNA 测序。Illumina 标准方案将用于 RNA 测序，读计数将用于测量基因表达。
分析：直接输入，多逻辑回归将用于产生比值比，表达在模型中控制其他预测因子/协变量时每个解释变量的相对风险。
结论：这项研究是第一个对与 LEFx 个体从急性创伤后骨折疼痛转变为慢性疼痛相关的生物心理变量进行纵向描述的研究之一。该研究的结果将用于构建与 LEFx 后从急性疼痛状态转变为慢性疼痛状态的风险增加相关的生理、心理和遗传/基因组变量的预测风险模型。这项工作将更好地了解疼痛和相关变量随时间的变化轨迹；更好地了解与从急性疼痛转变为慢性疼痛风险相关的变量；并为未来确定改善 LEFx 个体结局的新治疗靶点提供基础。
Clin Exp Rheumatol. 2016
Nucleic Acids Res. 2016-1-4
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